FDA 510(k)

iHealth 紅外耳溫計 PT5

K 號：K212598 · 2022-01-28

決定日期2022-01-28

產品代碼FLL

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

iHealth infrared Ear thermometer PT5 is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K212598. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iHealth infrared Ear thermometer PT5?

iHealth infrared Ear thermometer PT5 is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K212598.

When did iHealth infrared Ear thermometer PT5 receive FDA 510(k) clearance?

iHealth infrared Ear thermometer PT5 received FDA 510(k) clearance on 2022-01-28, under 510(k) number K212598.

Who is the listed applicant for iHealth infrared Ear thermometer PT5?

The FDA 510(k) record lists Andon Health Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iHealth infrared Ear thermometer PT5?

The FDA product code for iHealth infrared Ear thermometer PT5 is FLL.

其他以 Andon Health Co, Ltd. 為申請人之記錄

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相關器械（代碼：FLL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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